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[Federal Register Volume 89, Number 239 (Thursday, December 12, 2024)]
[Notices]
[Pages 100512-100516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29291]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Statement of Organization, Functions, and Delegations of 
Authority

AGENCY: Office of the General Counsel, Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: This document revises and restates the Statement of 
Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services, Office of the General Counsel 
(OGC). Issuance of this Statement of Organization rescinds all prior 
Statements of Organization.

FOR FURTHER INFORMATION CONTACT: Rachel Park, Principal Deputy General 
Counsel, Office of the General Counsel, Office of the Secretary, 200

[[Page 100513]]

Independence Avenue SW, Washington, DC 20201. (202) 690-7741

SUPPLEMENTARY INFORMATION: The Office of the Secretary (OS) Statement 
of Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services, Office of the General Counsel 
(OGC), should now read as follows:

Section I. Mission

    The General Counsel is responsible for providing all legal services 
and advice to the Secretary, Deputy Secretary, and all subordinate 
organizational components of the Department. Under direction of the 
General Counsel, the Office of the General Counsel (OGC) serves as the 
sole officially designated source of legal advice and services to the 
Department's operating and staff divisions (except the OIG) to ensure 
that all the operating and staff divisions receive uniform advice. The 
Office of the Inspector General (OIG) is authorized to have its own 
Office of the Counsel to the Inspector General (OCIG). 62 FR 30859 
(June 5, 1997).

Section II. Organization and Leadership

    The Office of the General Counsel (OGC), under the supervision of a 
General Counsel, consists of:

1. Immediate Office
2. Divisions
3. Regional Offices

Subsection A. The Immediate Office of the General Counsel

    1. The Immediate Office of the General Counsel.
    The Immediate Office of the General Counsel consists of the General 
Counsel, their executive assistant(s), a Principal Deputy General 
Counsel, such other Deputy General Counsel as the Secretary deems 
appropriate and appoints, such other Special Assistant Deputy General 
Counsel, Senior Counsel, Senior Advisors and attorneys and staff as the 
General Counsel deems appropriate, and the Office of Legal Resources 
(OLR).
    a. The General Counsel. The General Counsel is the chief legal 
officer of the Department and is directly responsible to the Secretary.
    b. Principal Deputy General Counsel. The career Principal Deputy 
General Counsel is the second-ranking legal officer of the Department 
and is directly responsible to the General Counsel and the Secretary. 
The career Principal Deputy General Counsel is the ``first assistant'' 
to the General Counsel within the meaning of the Vacancies Reform Act 
of 1998, 5 U.S.C. 3345 et seq.
    c. Deputy General Counsels. The Deputy General Counsels report to 
the General Counsel and each shall be responsible for overseeing such 
substantive legal areas and corresponding OGC portfolios as designated 
by the General Counsel.
    i. Career Deputy General Counsel. One or more career Deputy General 
Counsels may be appointed to the Immediate Office. Career Deputy 
General Counsels (including the career Principal Deputy General 
Counsel) will generally be responsible for OGC management and 
operations, oversight of OLR, and such litigation, substantive, or 
programmatic portfolios and other duties as determined by the General 
Counsel. For performance evaluation purposes, a career deputy will 
serve as the rating official for all Associate General Counsels, Chief 
Counsels, the OLR Director, and any career Senior Counsel or Senior 
Advisor.
    ii. Non-Career Deputy General Counsel. One or more non-career 
Deputy General Counsels may be appointed to the Immediate Office. Each 
non-career Deputy shall report to the General Counsel and shall be 
assigned oversight of one or more portfolios within the Office of the 
General Counsel.
    iii. Special Assistant Deputy General Counsel. The General Counsel 
may designate one or more attorneys to act as a special assistant and 
to carry the title Special Assistant Deputy General Counsel. Any 
Special Assistant Deputy General Counsel shall report directly to the 
General Counsel or to such Deputy General Counsel as the General 
Counsel may designate.
    d. Senior Counsel, Special Counsel, or Senior Advisor to the 
General Counsel: Senior Counsels, Special Counsels, or Senior Advisors 
to the General Counsel perform such duties as may be assigned to them 
by the General Counsel, Principal Deputy General Counsel, or Deputy 
General Counsel.
    2. Order of Succession.
    a. General Counsel Vacancy. In the event of a ``vacancy'' in the 
position of General Counsel as a result of death, resignation, or an 
inability to perform the functions and duties of the office, the 
Principal Deputy General Counsel shall act in the General Counsel's 
stead, or serve as the Acting General Counsel as dictated by the 
Vacancies Reform Act of 1998, 5 U.S.C. 3345 et seq. unless the 
President designates another Acting General Counsel pursuant to the 
Act.
    b. Principal Deputy General Counsel Vacancy. In the event of 
vacancies in offices of both the General Counsel and the Principal 
Deputy General Counsel, the non-career Deputy General Counsel with the 
greatest seniority in that position shall perform the functions of or 
serve as the Acting General Counsel as dictated by the Vacancies Reform 
Act of 1998, unless the President designates another Acting General 
Counsel pursuant to the Act. In the event that vacancies extend to or 
include all non-career deputies, then the career Deputy General Counsel 
with the greatest seniority in that position shall act in or serve as 
the Acting General Counsel as dictated by the Vacancies Reform Act of 
1998.
    3. The Office of Legal Resources, Immediate Office of the General 
Counsel
    The Office of Legal Resources shall be headed by a Director, who is 
responsible for providing personnel, budget, correspondence, and 
information technology support to the Office of the General Counsel as 
well as providing legal information law services through the Law 
Library. The Director shall report to the career Deputy General Counsel 
responsible for OGC management and operations. The Office of Legal 
Resources includes six branches, each headed by a Director or Manager:

a. Budget
b. Correspondence
c. Human Capital Services
d. Information Technology
e. Legal Information
f. Procurement, Policy and Planning

Subsection B. Divisions

    Each OGC Division is under the general supervision of the General 
Counsel. Each OGC office head reports directly to the designated Deputy 
General Counsel on substantive legal matters, litigation strategy, and 
other matters as directed by the General Counsel. There are ten 
divisions in the Office of the General Counsel:
    1. The Advanced Research Projects Agency for Health (ARPA-H) 
Division shall be headed by a Chief Counsel/Associate General Counsel, 
who reports to the General Counsel through a designated Deputy General 
Counsel.
    2. The Centers for Medicare & Medicaid Services Division (CMSD) 
shall be headed by an Associate General Counsel, who reports to the 
General Counsel through a designated Deputy General Counsel. The 
Division consists of three groups each headed by a Deputy Associate 
General Counsel reporting to the Associate General Counsel:

a. Litigation Group
b. Program Review Group
c. Program Integrity Group

    The Associate General Counsel may designate supervisory attorneys 
to report to the Deputy Associate General Counsels as appropriate.

[[Page 100514]]

    3. The Children, Families, and Aging Division (CFAD) shall be 
headed by an Associate General Counsel, who reports to the General 
Counsel through a designated Deputy General Counsel. CFAD also includes 
a Deputy Associate General Counsel, who reports to the Associate 
General Counsel. The Associate General Counsel may designate 
supervisory attorneys to report to the Deputy Associate General Counsel 
as appropriate.
    4. The Civil Rights and Health Privacy Division (CRD) shall be 
headed by an Associate General Counsel, who reports to the General 
Counsel through a designated Deputy General Counsel. The Division 
consists of two groups, each headed by a Deputy Associate General 
Counsel who reports to the Associate General Counsel:

a. Civil Rights Team
b. Health Privacy Team

    5. The Ethics Division (ETH) shall be headed by an Associate 
General Counsel, who reports to the General Counsel through a 
designated Deputy General Counsel. The Division consists of two 
branches, each headed by a Deputy Associate General Counsel reporting 
to the Associate General Counsel:

a. Ethics Advice and Policy Branch
b. Ethics Program Administration Branch

    The Associate General Counsel and Deputy Associate General Counsel 
for Ethics Advice and Policy simultaneously serve by secretarial 
delegation as the Department's Designated Agency Ethics Official and 
Alternate Designated Agency Ethics Official, respectively.
    6. The Food and Drug Division (FDD) shall be headed by a Chief 
Counsel who shall be either a Deputy General Counsel or an Associate 
General Counsel. In the event that the Chief Counsel is an Associate 
General Counsel, they shall report to the General Counsel through a 
designated Deputy General Counsel. In the event that the Chief Counsel 
is a Deputy General Counsel, the Associate General Counsel shall report 
to the Chief Counsel. The Division consists of two branches, each of 
which is headed by one or more Deputy Associate General Counsels who 
report to the Associate General Counsel:

a. Litigation Branch
b. Program Review Branch

    7. The General Law Division (GLD) shall be headed by an Associate 
General Counsel, who reports to the General Counsel through a 
designated Deputy General Counsel. The Division consists of two 
branches, each headed by a Deputy Associate General Counsel reporting 
to the Associate General Counsel, as well as Assistant Deputy Associate 
General Counsels selected by the Associate General Counsel to provide 
oversight and supervision of Sections within the Division:

a. Claims and Employment Law Branch
b. Procurement, Fiscal, and Information Law Branch

    8. The Legislation Division (GCL) shall be headed by an Associate 
General Counsel, who reports to the General Counsel through a 
designated Deputy General Counsel.
    9. The Public Health Division (Ph.D.) shall be headed by an 
Associate General Counsel, who reports to the General Counsel through a 
designated Deputy General Counsel. The Division consists of four 
branches, each of which is headed by a Deputy Associate General Counsel 
reporting to the Associate General Counsel:

a. Indian Health Service (IHS) Branch
b. Centers for Disease Control and Prevention Branch
c. National Institutes of Health Branch
d. Public Health and Science Branch

    10. The National Complex Litigation and Investigations Division 
(NCLID) shall be headed by an Associate General Counsel, who reports to 
the General Counsel through a designated Deputy General Counsel. The 
Division shall also have a designated Deputy Associate General Counsel 
for E-Discovery, who reports to the Associate General Counsel.

Subsection C. Regional Offices

    Each OGC Regional Office is under the general supervision of the 
General Counsel. Each OGC office head reports directly to the 
designated Deputy General Counsel on substantive legal matters, 
litigation strategy, and other matters as directed by the General 
Counsel. There are ten OGC regional offices in the ten HHS Regional 
Offices:
    1. OGC Region 1--Boston shall be headed by a Chief Counsel, who 
reports to the General Counsel through a designated Deputy General 
Counsel.
    2. OGC Region 2--New York City shall be headed by a Chief Counsel, 
who reports to the General Counsel through a designated Deputy General 
Counsel. The office has a Deputy Chief Counsel, who reports to the 
Chief Counsel.
    3. OGC Region 3--Philadelphia shall be headed by a Chief Counsel, 
who reports to the General Counsel through a designated Deputy General 
Counsel. The office has a Deputy Chief Counsel, who reports to the 
Chief Counsel.
    4. OGC Region 4--Atlanta shall be headed by a Chief Counsel, who 
reports to the General Counsel through a designated Deputy General 
Counsel. The office consists of two branches, each of which is headed 
by a Deputy Chief Counsel reporting to the Chief Counsel:

a. HHR Branch (Administration for Children and Families (ACF) and 
Centers for Medicare & Medicaid Services (CMS) Program Advice and 
Litigation)
b. General Law Branch (Personnel and Contract Advice and Litigation

    5. OGC Region 5--Chicago shall be headed by a Chief Counsel, who 
reports to the General Counsel through a designated Deputy General 
Counsel. The office has two Deputy Chief Counsels, each of whom reports 
to the Chief Counsel and oversees legal work in those program areas 
assigned to them.
    6. OGC Region 6--Dallas shall be headed by a Chief Counsel, who 
reports to the General Counsel through a designated Deputy General 
Counsel. The office consists of two branches, each of which is headed 
by a Deputy Chief Counsel who reports to the Chief Counsel:

a. HHR Branch (Advice and Litigation)
b. General Law Branch (Advice and Litigation)

    7. OGC Region 7--Kansas City shall be headed by a Chief Counsel, 
who reports to the General Counsel through a designated Deputy General 
Counsel.
    8. OGC Region 8--Denver shall be headed by a Chief Counsel, who 
reports to the General Counsel through a designated Deputy General 
Counsel. The office has a Deputy Chief Counsel, who reports to the 
Chief Counsel.
    9. OGC Region 9--San Francisco shall be headed by a Chief Counsel, 
who reports to the General Counsel through a designated Deputy General 
Counsel. The office consists of two branches, each of which is headed 
by a Deputy Chief Counsel, who reports to the Chief Counsel:

a. Employment, IHS, Office of Civil Rights (OCR)
b. ACF, CMS, Information Requests

    10. OGC Region 10--Seattle shall be headed by Chief Counsel, who 
reports to the General Counsel through a designated Deputy General 
Counsel. The office has a Deputy Chief Counsel, who reports to the 
Chief Counsel.

Section III. Functions

Subsection A. The General Counsel and the Office of the General Counsel

    1. The General Counsel. The General Counsel is authorized to 
promulgate such directives and issue such legal opinions as may be 
necessary to carry

[[Page 100515]]

out the responsibilities of the Office. The General Counsel, directly 
or through attorneys in the Office of the General Counsel, undertakes 
the following activities unless an applicable statute provides 
otherwise or the General Counsel has delegated the responsibility 
elsewhere:
    a. Furnishes all legal services and advice to the Secretary, Deputy 
Secretary, and all offices, branches, and units of the Department in 
connection with the operations and administration of the Department and 
its programs, unless otherwise expressly delegated by statute to 
another agency or official.
    b. Furnishes legal services and advice on such other matters as may 
be submitted by the Secretary, the Deputy Secretary, any other senior 
leaders, and other persons authorized by the Secretary to request such 
service or advice.
    c. Represents the Department in all litigation when such direct 
representation is not precluded by law, and in other cases, supervises 
the conduct of such litigation.
    d. Acts as the Department's representative in communicating with 
the Department of Justice, including all United States Attorneys, on 
all civil and criminal matters.
    e. Acts as the Department's representative in communicating with 
Office of White House Counsel and the Offices of General Counsel for 
any other Department or Agency.
    f. Authorizes indemnification of Department employees, as 
appropriate, pursuant to 45 CFR part 36.
    g. Provides legal review of all proposals for Federal legislation 
originating within the Department, as well as all proposed Federal 
legislation submitted to the Department or to any operating division of 
the Department for comment; as appropriate, prepares or reviews reports 
and letters to congressional committees, the Office of Management and 
Budget, and others on proposed Federal legislation; and prescribes 
procedures to govern the routing and review, within the Department, of 
material relating to proposed Federal legislation.
    h. Supervises all legal activities of the Department and its 
operating and staff divisions, except the OIG.
    i. Ensures that no one in the Department, other than those in OGC 
or expressly authorized by the General Counsel to do so, provides any 
legal advice to anyone in the Department that implies that they are 
functioning as a departmental lawyer.

Subsection B. Functions and Responsibilities of the OGC Divisions

    The Divisions within OGC provide legal counsel to their clients, as 
described below, subject to the professional supervision and control of 
the General Counsel and the designated Deputy General Counsel.
    1. The Advanced Research Projects Agency for Health (ARPA-H) 
Division. The ARPA-H Division provides legal services to ARPA-H.
    2. Centers for Medicare & Medicaid Services Division (CMSD). CMSD 
provides legal services to the Centers for Medicare & Medicaid Services 
(CMS), the Office of Medicare Hearings and Appeals (OMHA) and the 
Departmental Appeals Board (DAB). CMSD also provides legal services to 
the Assistant Secretary for Technology Policy and Office of the 
National Coordinator for Health Information Technology (ASTP/ONC).
    3. Children, Families, and Aging Division (CFAD). CFAD provides 
legal services to the Administration for Children and Families and its 
various agencies, including the Office of Refugee Resettlement and 
Administration for Community Living. In addition, the Division advises 
the Department on the 477 initiative authorized by the Indian 
Employment, Training, and Related Services Demonstration Act of 2017.
    4. Civil Rights and Health Privacy Division (CRD). CRD provides 
legal services for the Office for Civil Rights (OCR) and provides 
advice with respect to the enforcement of civil rights laws, conscience 
statutes, the Health Insurance and Portability and Accountability Act 
of 1996 (Social Security Act sec. 1171 et seq.), the Health Information 
Technology for Economic and Clinical Health (HITECH) Act, and the rules 
implementing them with respect of HHS-funded programs and activities. 
CRD does not defend claims filed by HHS employees.
    5. Ethics Division (ETH). ETH administers and oversees Department-
wide implementation of comprehensive government ethics program 
requirements under the Ethics in Government Act of 1978 as amended, 
Executive Order 12731, and implementing regulations at 5 CFR part 2638. 
This includes providing legal advice, training, and policy instruction 
and guidance consistent with core ethics program elements, including 
conflict of interest, impartiality, financial disclosure, outside 
activities, political activity, lobbying, pre-clearance ethics 
agreements, gifts, and travel payments from non-Federal sources.
    ETH also communicates on matters related to government ethics with 
the Office of Counsel to the President, the Office of Government 
Ethics, the Office of Special Counsel, the Office of the Inspector 
General, Special Investigations Unit, the Department of Justice, the 
Office of Personnel Management, and the General Services 
Administration.
    In addition, ETH develops component-specific conduct regulations 
and implementing procedures.
    6. Food and Drug Division (FDD). FDD acts as the legal advisor to 
the Commissioner of Food and Drugs and provides legal services to the 
Food and Drug Administration (FDA). This includes representing the FDA 
in connection with judicial and administrative proceedings involving 
programs administered by the FDA, providing legal advice and policy 
guidance for programs administered by the FDA, and reviewing proposed 
and final regulations and Federal Register notices prepared by FDA. FDD 
acts as the Department and FDA's primary liaison to the Department of 
Justice and other Federal departments for programs administered by FDA; 
all criminal prosecutions, investigations, and civil matters may be 
referred to the Department of Justice only through or in consultation 
with the Chief Counsel.
    7. General Law Division (GLD). GLD provides legal services on 
business management activities and administrative operations including 
procurement, contracting, personnel, budget, appropriations, Federal 
real property, employment, information disclosure and privacy (but not 
health information privacy) and Federal tort claims. In addition, the 
Associate General Counsel for GLD acts as the Department Claims 
Officer.
    8. Legislation Division (GCL). GCL:
    a. Drafts all proposed legislation originating in the Department, 
reviews specifications for such proposed legislation, and reviews all 
proposed legislation submitted to the Department or to any constituent 
unit of the Department for comment.
    b. Prepares or reviews reports and letters to congressional 
committees, the Office of Management and Budget, and others on proposed 
legislation.
    c. Reviews proposed testimony of Department officials before 
congressional committees relating to pending or proposed legislation.
    d. Acts as Department liaison with the Office of Management and 
Budget on legislative matters.

[[Page 100516]]

    e. Prescribes procedures to govern the routing and review, within 
the Department, of material relating to proposed Federal legislation.
    9. National Complex Litigation and Investigation Division (NCLID). 
NCLID provides legal services to all agencies and offices within the 
Department, as directed by the General Counsel. NCLID provides legal 
services in connection with complex litigation or anticipated complex 
litigation by or against the Department. Such litigation may include 
cases for which other OGC divisions or regional offices request NCLID 
participation, cases spanning multiple OGC divisions or regional 
offices, or cases outside the scope of other OGC divisions or regional 
offices. NCLD administers the OGC-wide e-discovery program and 
coordinates the use of e-discovery technology with agencies and offices 
within the Department.
    10. Public Health Division (Ph.D.). Ph.D. provides legal services 
to all Public Health Service agencies (except to FDA) and their 
programs, including the Office of the Surgeon General and the 
Commissioned Corps of the U.S. Public Health Service. Represented 
Public Health Service agencies include, but are not limited to: (i) the 
Office of the Assistant Secretary for Health, and its various programs; 
(ii) the Office of the Secretary's Office of Minority Health; (iii) the 
Centers for Disease Control and Prevention; (iv) the National 
Institutes of Health; (v) the Health Resources and Services 
Administration; (vi) the Indian Health Service; (vii) the Substance 
Abuse and Mental Health Services Administration; (viii) the Agency for 
Healthcare Research and Quality, (ix) the Administration for Strategic 
Preparedness and Response, and (x) the Agency for Toxic Substances and 
Disease Registry.

Subsection C. Functions and Responsibilities of the OGC Regional 
Offices

    An OGC regional office is located in each of the ten HHS regions, 
each of which is led by a Regional Director appointed by the Secretary. 
The Chief Counsel of each Region is the Department's legal 
representative in that Region. Regional offices within OGC provide a 
full range of legal services, subject to the professional supervision 
and direction of the General Counsel and the designated Deputy General 
Counsel. This includes providing legal advice and representation in 
administrative and judicial litigation regarding programs operated by 
the Centers for Medicare and Medicaid Services, the Administration for 
Children and Families, the Administration for Community Living, and 
Public Health Service agencies including the Indian Health Service, the 
Health Resources and Services Administration, the Substance Abuse and 
Mental Health Services Administration, and the Centers for Disease 
Control and Prevention; providing legal services to the Office for 
Civil Rights, including advice and representation in administrative and 
judicial litigation with respect to the enforcement of civil rights 
laws and the Health Insurance and Portability and Accountability Act of 
1996 (Social Security Act sec. 1171 et seq.); and providing legal 
advice and representation in administrative and judicial litigation 
relating to business management activities and administrative 
operations, such as employment and labor relations, information 
disclosure and privacy, Federal tort claims, and suspensions, 
disallowances, and other recoveries of payments made under HHS 
programs, of HHS components operating in their regions.
    The HHS regional offices are located in the following cities and 
cover all States and territories of the United States, as well as three 
independent states in the Pacific.
    1. OGC Region 1--Boston covers Connecticut, Maine, Massachusetts, 
New Hampshire, Rhode Island, and Vermont.
    2. OGC-Region 2--New York City covers New York, New Jersey, Puerto 
Rico, and the Virgin Islands.
    3. OGC Region 3--Philadelphia covers Delaware, Maryland, 
Pennsylvania, Virginia, West Virginia, and the District of Columbia.
    4. OGC Region 4--Atlanta covers Alabama, Florida, Georgia, 
Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee.
    5. OGC Region 5--Chicago covers Illinois, Indiana, Ohio, Michigan, 
Minnesota, Wisconsin, and the Bemidji Area Office of the Indian Health 
Service (IHS).
    6. OGC Region 6--Dallas covers Arkansas, Louisiana, New Mexico, 
Oklahoma, Texas, as well as the Albuquerque and Oklahoma City Area 
Offices of the Indian Health Service (IHS).
    7. OGC Region 7--Kansas City (MO) covers Iowa, Kansas, Missouri, 
and Nebraska.
    8. OGC Region 8--Denver covers Colorado, Montana, North Dakota, 
South Dakota, Utah, Wyoming, as well as the Great Plains and Billings 
Area Offices of the Indian Health Service (IHS).
    9. OGC Region 9--San Francisco covers Arizona, California, Hawaii, 
Nevada, Guam, American Samoa, Commonwealth of the Northern Mariana 
Islands, the Federated States of Micronesia, the Republic of the 
Marshall Islands, the Republic of Palau, as well as the California 
Area, Navajo Area, Phoenix Area, and Tucson Area Offices of the Indian 
Health Services (IHS).
    10. OGC Region 10--Seattle covers Alaska, Idaho, Oregon, 
Washington, as well as the Alaska Area and Portland Area Offices of the 
Indian Health Services (IHS).

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-29291 Filed 12-11-24; 8:45 am]
BILLING CODE 4150-26-P
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